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IMMUNE CORRELATES ANALYSIS OF THE ENSEMBLE SINGLE AD26.COV2.S DOSE VACCINE EFFICACY CLINICAL TRIAL
Fong, Youyi et al. | Date Issued: 2022
Author
Fong, Youyi
McDermott, Adrian B.
Benkeser, David
Roels, Sanne
Stieh, Daniel J.
Vandebosch, An
Le Gars, Mathieu
Roey, Griet A. Van
Houchens, Christopher R.
Martins, Karen
Jayashankar, Lakshmi
Castellino, Flora
Amoa-Awua, Obrimpong
Basappa, Manjula
Flach, Britta
Lin, Bob C.
Moore, Christopher
Naisan, Mursal
Naqvi, Muhammed
Narpala, Sandeep
O'Connell, Sarah
Mueller, Allen
Serebryannyy, Leo
Castro, Mike
Wang, Jennifer
Petropoulos, Christos J.
Luedtke, Alex
Hyrien, Ollivier
Lu, Yiwen
Yu, Chenchen
Borate, Bhavesh
Laan, Lars W. P. Van Der
Hejazi, Nima S.
Kenny, Avi
Carone, Marco
Wolfe, Daniel N.
Sadoff, Jerald
Gray, Glenda E.
Grinsztejn, Beatriz
Goepfert, Paul A.
Little, Susan J.
Sousa, Leonardo Paiva de
Maboa, Rebone
Randhawa, April K.
Andrasik, Michele P.
Hendriks, Jenny
Truyers, Carla
Struyf, Frank
Schuitemaker, Hanneke
Douoguih, Macaya
Kublin, James G.
Corey, Lawrence
Neuzil, Kathleen M.
Carpp, Lindsay N.
Follmann, Dean
Gilbert, Peter B.
Koup, Richard A.
Donis, Ruben O.
Affilliation
Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA / Fred Hutchinson Cancer Center. Public Health Sciences Division. Seattle, WA, USA.
National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA.
Emory University. Rollins School of Public Health. Department of Biostatistics and Bioinformatics. Atlanta, GA, USA.
Janssen R&D. a division of Janssen Pharmaceutica NV. Beerse, Belgium.
Janssen Vaccines and Prevention. Leiden, the Netherlands.
Janssen R&D. a division of Janssen Pharmaceutica NV. Beerse, Belgium.
Janssen Vaccines and Prevention. Leiden, the Netherlands.
Janssen Vaccines and Prevention. Leiden, the Netherlands.
Biomedical Advanced Research and Development Authority. Washington, DC, USA.
Biomedical Advanced Research and Development Authority. Washington, DC, USA.
Biomedical Advanced Research and Development Authority. Washington, DC, USA.
Biomedical Advanced Research and Development Authority. Washington, DC, USA.
National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA.
National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA.
National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA.
National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA.
National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA.
National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA.
National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA.
National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA.
National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA.
National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA.
National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA.
National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA.
National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA.
LabCorp-Monogram Biosciences. South San Francisco, CA, USA.
University of Washington. Department of Statistics. Seattle, WA, USA.
Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA / Fred Hutchinson Cancer Center. Public Health Sciences Division. Seattle, WA, USA.
Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA.
Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA.
Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA.
Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA / University of Washington. Department of Statistics. Seattle, WA, USA.
Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA / Weill Cornell Medicine. Department of Population Health Sciences. School of Public Health. Division of Biostatistics. New York, NY, USA.
University of Washington School of Public Health. Department of Biostatistics. Seattle, WA, USA.
University of Washington School of Public Health. Department of Biostatistics. Seattle, WA, USA.
Biomedical Advanced Research and Development Authority. Washington, DC, USA.
Janssen Vaccines and Prevention. Leiden, the Netherlands.
University of the Witwatersrand. Faculty of Health Sciences. Perinatal HIV Research Unit. Johannesburg, South Africa / South African Medical Research Council. Cape Town, South Africa.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
University of Alabama at Birmingham. Department of Medicine. Division of Infectious Diseases. Birmingham, AL, USA.
University of California San Diego. Division of Infectious Diseases. La Jolla, CA, USA.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
Ndlovu Elandsdoorn Site. Limpopo, Dennilton, South Africa.
Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA.
Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA.
Janssen Vaccines and Prevention. Leiden, the Netherlands.
Janssen R&D. a division of Janssen Pharmaceutica NV. Beerse, Belgium.
Janssen R&D. a division of Janssen Pharmaceutica NV. Beerse, Belgium.
Janssen Vaccines and Prevention. Leiden, the Netherlands.
Janssen Vaccines and Prevention. Leiden, the Netherlands.
Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA.
Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA / University of Washington. Department of Laboratory Medicine and Pathology. Seattle, WA, USA.
University of Maryland School of Medicine. Center for Vaccine Development and Global Health. Baltimore, MD, USA.
Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA.
National Institutes of Health. National Institute of Allergy and Infectious Diseases. Biostatistics Research Branch. Bethesda, MD, USA.
Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA / Fred Hutchinson Cancer Center. Public Health Sciences Division. Seattle, WA, USA / University of Washington School of Public Health. Department of Biostatistics. Seattle, WA, USA.
National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA.
Biomedical Advanced Research and Development Authority. Washington, DC, USA.
Abstract
Measuring immune correlates of disease acquisition and protection in the context of a clinical trial is a prerequisite for improved vaccine design. We analysed binding and neutralizing antibody measurements 4 weeks post vaccination as correlates of risk of moderate to severe-critical COVID-19 through 83 d post vaccination in the phase 3, double-blind placebo-controlled phase of ENSEMBLE, an international randomized efficacy trial of a single dose of Ad26.COV2.S. We also evaluated correlates of protection in the trial cohort. Of the three antibody immune markers we measured, we found most support for 50% inhibitory dilution (ID50) neutralizing antibody titre as a correlate of risk and of protection. The outcome hazard ratio was 0.49 (95% confidence interval 0.29, 0.81; P = 0.006) per 10-fold increase in ID50; vaccine efficacy was 60% (43%, 72%) at non-quantifiable ID50 (<2.7 IU50 ml-1) and increased to 89% (78%, 96%) at ID50 = 96.3 IU50 ml-1. Comparison of the vaccine efficacy by ID50 titre curves for ENSEMBLE-US, the COVE trial of the mRNA-1273 vaccine and the COV002-UK trial of the AZD1222 vaccine supported the ID50 titre as a correlate of protection across trials and vaccine types.
Keywords
COVID-19
ENSEMBLE
Vaccine efficacy
 
Publisher
Nature
Citation
FONG, Youyi et al. Immune correlates analysis of the ENSEMBLE single Ad26.COV2.S dose vaccine efficacy clinical trial. Nature microbiology, v. 7, n. 12, p. 1996-2010, 2022.
DOI
10.1038/s41564-022-01262-1
ISSN
2058-5276